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Patient-Oriented Research to Optimize Cochlear Implant Outcomes

24 juni 2026 uppdaterad av: Aaron Moberly, Vanderbilt University Medical Center

The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:

Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (> 6 months of CI use).

Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users.

The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.

Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Specific Aim 1: Along with collection of demographic/audiologic and datalogging variables, participants will be tested for auditory spectro-temporal resolution and cognitive-linguistic functions. Functional near-infrared spectroscopy (fNIRS) will be collected, reflecting cortical responses to speech.

Using cluster analyses, investigators will test the hypothesis that different profiles exist, with different CI users demonstrating different patterns of bottom-up processing, top-down processing, or both. Patient-reported outcomes of CI-related quality of life, communication, and satisfaction will also be assessed to relate speech recognition to broader real world functioning.

Specific Aim 2: The "auditory" intervention includes a two-pronged approach of, first, verifying fitting via upper stimulation levels shaped to electrically evoked stapedial reflex thresholds (eSRTs) and lower stimulation levels fit to CI-aided detection between 20 and 30 dB Hearing Loss (HL), and second, image-guided cochlear implant programming (IGCIP) to reduce CI channel interaction. The "cognitive" intervention consists of computerized auditory-cognitive training using a well-established home-based training program focused on improving speech recognition through engaging cognitive processes known to be integral for successful listening in challenging conditions.

CI users from Aim #1 will be randomized to one of three groups:

  1. Group 1 receives an auditory intervention followed by a cognitive intervention (AC group);
  2. Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University Medical Center
        • Kontakt:
        • Huvudutredare:
          • Aaron Moberly, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. Adults between ages of 18 years and 95 years
  2. Native language is American English
  3. Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
  4. Experience of >6 of CI use.

Exclusion Criteria:

  1. Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
  2. Known diagnosis of dementia
  3. Under the age of 18 years
  4. Unable to read and write in English (WRAT score <70)
  5. Poorer than 20/40 near vision on near-vision screening.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Group 1 - Auditory Intervention (AC)
Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training.
Beteende: AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

Beteende: CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
Aktiv komparator: Group 2 - Cognitive Intervention (CA)
Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training.
Beteende: AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

Beteende: CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
Inget ingripande: Group 3 - Control
Group 3 will be the control group and not receive either training.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
Tidsram: at ~8 weeks study completion
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. This score is from 0 to 100% words correct.
at ~8 weeks study completion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cochlear Implant Quality of Life (CIQOL-35)
Tidsram: at ~8 weeks study completion
This measures assesses six domains: communication, emotional, entertainment, environment, listening effort, and social. Each domain is scored between 0 and 100 points.
at ~8 weeks study completion

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vanderbilt University Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 juni 2031

Avslutad studie (Beräknad)

1 juni 2032

Studieregistreringsdatum

Först inskickad

9 maj 2026

Först inskickad som uppfyllde QC-kriterierna

24 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 260536

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

This is a feasibility study. De-identified individual participant data (IPD) collected in this study may be available to other researchers (e.g., outside the primary research group) Data may be shared with others if requested and necessary agreements are made. This is still undecided as this is a feasibility trial.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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